Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

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The Case Of The Half Pill: AI As Outsourcing Detective

A number of patients report receiving half a pill in a blister pack of their prescribed medicine. The initial sponsor reaction is to place the problem at an external partner’s production or packaging line. But overall responsibility lies with the sponsor, and the true extent of the problem is hard to detect. Enter AI. Says Damiano Dragone, a long-term Quality expert, AI and biopharma professionals throughout the supply chain can join in a new “logic and creativity" to improve our industry on behalf of patients.

GUEST COLUMNISTS

Are You Falling Behind On Intelligent Pharmaceutical Manufacturing?
With a focus on small molecule drug product manufacture, let's take a closer look at the efficiencies gained through closed-loop control, PAT, digital twins, and more.
DEA Reveals Hidden Costs Of Analytical Validation Guidelines
By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.
Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.
FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.
CDMO Selection Beyond Capabilities And Price
Some of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story.
August 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
Building Sustainable Biopharma Supply Chains Starts With Procurement
Nearly all the industry's emissions happen upstream from core manufacturing functions. This puts sustainability almost entirely on the shoulders of purchasing.
Why You Should Measure Comparability Debt Before Ever Starting A Study
When analytical capability and process understanding fail to keep pace with a drug candidate, the technical uncertainty creates debt that's difficult to pay down.

PHARMA OUTSOURCING WHITE PAPERS

Mastering Pharmaceutical Cleaning Validation Methods
View the basics of cleaning validation and discuss the support services you should seek from your critical cleaning products supplier to optimize your cleaning validation process.

Data-Centric Organoid Services For Predictive Drug Response And Next-Generation Oncology Research
Patient-derived organoids are gaining traction as translational tools in oncology, but their value depends on the quality and context of the data they generate, not the models alone.
Harnessing Chemistry For Scalable Manufacture Of Lipids Used In mRNA Delivery
Discover how scalable lipid nanoparticle (LNP) technology is revolutionizing mRNA-based therapies and shaping the future of treatment innovation.
A CFO's Guide To Driving Growth
Navigate the evolving biotech landscape and secure venture capital with insights on strategic partnerships and investor expectations.
The Analytical Advantage Across The Development Lifecycle
Integrated, regulatory‑ready analytics help accelerate development, strengthen submissions, and ensure consistent product quality throughout the pharmaceutical lifecycle.
An Integrated Analytical Approach To Lipase Risk Management In Biologics Development
Conventional HCP testing cannot confirm whether residual lipases remain enzymatically active. Here, the authors examine why functional activity data are essential for managing polysorbate-related stability risk in biologics development.